immunogenicity and safety of fractional doses of ipv intradermally vs full doses intramuscularly

Conditions: Poliomyelitis

Summary: the present study intends to investigate the use of fractional doses of sanofi pasteur's imovax polio injected intradermally. the primary objective will be to demonstrate the non-inferiority of fractional doses of imovax polio administered intradermally versus full doses of imovax polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.


Eligibility criteria:
inclusion criteria: * inclusion criteria to be checked at the screening visit (sc): * aged 0 to 7 days on the day of screening * born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * informed consent form signed by the parent(s) or other legally acceptable representative * subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures * inclusion criteria to be checked at the randomization visit (v01): * aged 42 to 50 days on the day of inclusion * subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures exclusion criteria: * exclusion criteria to be checked at the screening visit (sc): * planned participation in another clinical trial during the present trial period * illness that could interfere with trial conduct or completion, in the opinion of the investigator * receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response * history of seizures * known personal or maternal human immunodeficiency virus (hiv), hepatitis b antigen or hepatitis c seropositivity * thrombocytopenia or bleeding disorder contraindicating im injection * exclusion criteria to be checked at the randomization visit (v01): * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination * planned participation in another clinical trial during the present trial period * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances * chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response * receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except bcg, dtp-hib or hepatitis b vaccines, which can not be given within 10 days before or after any study vaccination) * history of seizures * known personal or maternal human immunodeficiency virus (hiv), hepatitis b antigen or hepatitis c seropositivity * history of poliomyelitis infection (confirmed either clinically, serologically or microbiologically) * previous vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine * thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (im) injection * febrile illness (temperature ≥38°c) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment

Keywords: poliomyelitis intradermal